subpart b. general and special hospitals ch. 101

34
Subpart B. GENERAL AND SPECIAL HOSPITALS Chap. Sec. 101. GENERAL INFORMATION ................................... 101.1 103. GOVERNANCE AND MANAGEMENT ......................... 103.1 105. ADMISSION AND DISCHARGE ............................... 105.1 107. MEDICAL STAFF ............................................ 107.1 109. NURSING SERVICES ........................................ 109.1 111. DIETETIC SERVICES ........................................ 111.1 113. PHARMACY SERVICES ...................................... 113.1 115. MEDICAL RECORD SERVICES ............................... 115.1 117. EMERGENCY SERVICES .................................... 117.1 119. OUTPATIENT SERVICESAND SHORT-TERM PROCEDURE UNITS ...................................................... 119.1 121. SOCIAL WORK SERVICES ................................... 121.1 123. ANESTHESIA AND RESPIRATORY SERVICES ................. 123.1 125. LABORATORY SERVICES .................................... 125.1 127. RADIOLOGY SERVICES ..................................... 127.1 129. NUCLEAR MEDICINE SERVICES ............................. 129.1 131. REHABILITATION SERVICES ................................ 131.1 133. SPECIAL CARE UNITS ....................................... 133.1 135. SURGICAL SERVICES ....................................... 135.1 136. OPEN HEART SURGICAL SERVICES ......................... 136.1 137. OBSTETRICAL SERVICES ................................... 137.1 138. CARDIAC CATHETERIZATION SERVICES .................... 138.1 139. NEONATAL SERVICES ....................................... 139.1 141. DENTAL SERVICES ......................................... 141.1 143. PODIATRY SERVICES ....................................... 143.1 145. PROFESSIONAL LIBRARY SERVICES ........................ 145.1 146. INFECTION CONTROL ...................................... 146.1 147. ENVIRONMENTAL SERVICES ................................ 147.1 149. CENTRAL SUPPLY SERVICES ................................ 149.1 151. FIRE, SAFETY AND DISASTER SERVICES .................... 151.1 153. INITIAL CONSTRUCTION AND CONTINUING OPERATING STANDARDS ................................... 153.1 155. PSYCHIATRIC SERVICES .................................... 155.1 157. [Reserved and Renumbered] ................................... 157.1 158. VITAL ORGAN TRANSPLANTATION SERVICES ............... 158.1 Source The provisions of this Subpart B adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631, unless otherwise noted. Notes of Decisions The Legislature has authorized the Department of Health to promulgate its rules and regulations concerning hospitals. Hospital Association of Pennsylvania v. MacLeod, 410 A.2d 731 (Pa. 1980). Cross References This subpart cited in 28 Pa. Code § 29.31 (relating to definitions); 55 Pa. Code § 1163.2 (relating to definitions); and 55 Pa. Code § 1163.402 (relating to definitions). Ch. 101 GENERAL INFORMATION 28 101-1 (373855) No. 482 Jan. 15

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Page 1: Subpart B. GENERAL AND SPECIAL HOSPITALS Ch. 101

Subpart B. GENERAL AND SPECIAL HOSPITALS

Chap. Sec.101. GENERAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101.1103. GOVERNANCE AND MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . 103.1105. ADMISSION AND DISCHARGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105.1107. MEDICAL STAFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107.1109. NURSING SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109.1111. DIETETIC SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111.1113. PHARMACY SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113.1115. MEDICAL RECORD SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115.1117. EMERGENCY SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117.1119. OUTPATIENT SERVICES AND SHORT-TERM PROCEDURE

UNITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119.1121. SOCIAL WORK SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121.1123. ANESTHESIA AND RESPIRATORY SERVICES . . . . . . . . . . . . . . . . . 123.1125. LABORATORY SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125.1127. RADIOLOGY SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127.1129. NUCLEAR MEDICINE SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129.1131. REHABILITATION SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131.1133. SPECIAL CARE UNITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133.1135. SURGICAL SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135.1136. OPEN HEART SURGICAL SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . 136.1137. OBSTETRICAL SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137.1138. CARDIAC CATHETERIZATION SERVICES . . . . . . . . . . . . . . . . . . . . 138.1139. NEONATAL SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139.1141. DENTAL SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141.1143. PODIATRY SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143.1145. PROFESSIONAL LIBRARY SERVICES . . . . . . . . . . . . . . . . . . . . . . . . 145.1146. INFECTION CONTROL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146.1147. ENVIRONMENTAL SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147.1149. CENTRAL SUPPLY SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149.1151. FIRE, SAFETY AND DISASTER SERVICES . . . . . . . . . . . . . . . . . . . . 151.1153. INITIAL CONSTRUCTION AND CONTINUING

OPERATING STANDARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153.1155. PSYCHIATRIC SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155.1157. [Reserved and Renumbered] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157.1158. VITAL ORGAN TRANSPLANTATION SERVICES . . . . . . . . . . . . . . . 158.1

Source

The provisions of this Subpart B adopted December 9, 1977, effective December 10, 1977, 7 Pa.B.3631, unless otherwise noted.

Notes of Decisions

The Legislature has authorized the Department of Health to promulgate its rules and regulationsconcerning hospitals. Hospital Association of Pennsylvania v. MacLeod, 410 A.2d 731 (Pa. 1980).

Cross References

This subpart cited in 28 Pa. Code § 29.31 (relating to definitions); 55 Pa. Code § 1163.2 (relatingto definitions); and 55 Pa. Code § 1163.402 (relating to definitions).

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CHAPTER 101. GENERAL INFORMATION

GENERAL PROVISIONS

Sec.101.1. Legal base.101.2. Construction and amendment.101.3. Affected institutions.101.4. Definitions.101.5. [Reserved].101.6. Contact person.

EXCEPTIONS

101.11. Principle.101.12. Exceptions for innovative programs.101.13. Requests for exceptions.101.14. Revocation of exceptions.

CLASSIFICATION OF HOSPITALS

101.21. Classification.

HOSPITAL REQUIREMENTS

101.31. Hospital requirements.

INITIAL APPLICATION AND AUTHORIZATIONTO OPERATE A HOSPITAL

101.41. Principle.101.42. Building occupancy.101.42a. Code compliance.101.43. Request for application.

CONTINUING OPERATIONS

101.51. Policy.101.52. Nontransfer of license.101.53. Void license.101.54. Inpatient bed complement.

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101.55. Display of license.101.56. Licensure information/application.

INSPECTION AND SURVEY ACTIVITIES

101.61. Policy.101.62. Combined survey.101.63. Department responsibilities.101.64. Hospital responsibilities.101.65. Notice of biennial survey.101.66. Presurvey preparation.101.67. Access by the Department.101.68. Site survey coverage.101.69. Documentation.

POSTSURVEY PROCEDURES

101.71. Policy.101.72. Compliance directive.101.73. Submission of plan of correction.101.74. Content of plan of correction.101.75. Public inspection of compliance documents.

CONTINUING SURVEILLANCE

101.81. Unannounced surveys.

ISSUANCE OF LICENSE

101.91. Principle.101.92. Regular license.101.93. Provisional license.

REFUSAL OR REVOCATION

101.101. Grounds.101.102. Modification of license.101.103. Notice.101.104. Form of notice.

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CORRECTION OF DEFICIENCY

101.111. Policy.

HEARINGS

101.121. Demand for hearing.101.122. Conduct of proceedings.

ADDITIONAL REMEDIES

101.141. Principle.101.142. Withhold State funds.101.143. Judicial proceedings and injunctions.

CHILD ABUSE

101.151. Principle.

CIVIL RIGHTS

101.161. Principle.101.162. Civil rights compliance.101.163. Compliance requirements.101.164. Civil rights compliance records.101.165. Ethnic language barriers.

BED COMPLEMENT

101.171. [Reserved].101.172. Patient limits.

LICENSE FEES

101.181. Principle.

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MISCELLANEOUS PROVISIONS

101.191. Multiple-clinical facilities.101.192. Owners or controlling persons.101.193. Incorporated hospitals.101.194. Nonprofit corporation hospital.101.195. [Reserved].101.196. Notice of closure.

GENERAL PROVISIONS

§ 101.1. Legal base.(a) This subpart implements the powers and duties of the Department con-

tained in Chapter 8 of the act of July 19, 1979 (P. L. 130, No. 48) added by theact of July 12, 1980 (P. L. 655, No. 136) (35 P. S. §§ 448.801—448.821) knownas the Health Care Facilities Act and contained in article II of the act (62 P. S.§§ 201—209), as transferred to the Department in Reorganization Plan No. 5 of1973 (71 P. S. § 755-5).

(b) This subpart establishes standards which the Department hereby brings tothe attention of the officers or other persons having the management of licensedgeneral and special hospitals and which, it is the duty of such officers or suchother persons to adopt and to put into practice, pursuant to sections 803 and 806of the act (35 P. S. §§ 448.803 and 448.806).

(c) This subpart establishes the rules and regulations for visitation, examina-tion, and inspection of all licensed general and special hospitals, pursuant to sec-tions 810 and 813 of the act (35 P. S. §§ 448.810 and 448.813).

(d) This subpart establishes provisions for minimum standards in the con-struction, maintenance, and operation of hospitals and for the issuance of licensesfor general and special hospitals pursuant to sections 803 and 806 of the act.

Authority

The provisions of this § 101.1 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and under 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.1 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129 and 4281. Immediately preceding text appears at serial pages (52712) to (52713).

§ 101.2. Construction and amendment.This subpart establishes minimum standards with which licensed hospitals must

comply. This subpart is subject to revision and reasonable interpretation by theDepartment in accordance with the changing needs for health services in thisCommonwealth.

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Authority

The provisions of this § 101.2 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and under 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.2 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129 and 4281. Immediately preceding text appears at serial page (52713).

§ 101.3. Affected institutions.This subpart shall apply to all general and special hospitals within this Com-

monwealth except those hospitals operated by the United States.

Authority

The provisions of this § 101.3 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and under 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.3 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129 and 4281. Immediately preceding text appears at serial page (52713).

§ 101.4. Definitions.The following words and terms, when used in this subpart, have the following

meanings, unless the context clearly indicates otherwise:Act—Health Care Facilities Act (35 P. S. §§ 448.101—448.904).Advanced life support—The invasive prehospital and interhospital emer-

gency medical care of serious illness or injury by trained health professionaland allied health professional personnel under the medical command of a phy-sician.

Anesthetist—A generic term used to identify anesthesiologists, other quali-fied physician anesthetists, or qualified nurse or dentist anesthetists.

Authenticate—To verify authorship, for example, by written signature, iden-tifiable initials, or computer key; the use of rubber stamp signatures shall beacceptable under the following strict conditions:

(i) The practitioner whose signature the rubber stamp represents is theonly one who has possession of the stamp and is the only one who uses it.

(ii) The hospital maintains in its administrative offices a signed state-ment by the practitioner to the effect that he is the only person who possessesthe stamp and is the only one who will use it.Certified medical records practitioner—Either an Accredited Records Tech-

nician or a Registered Records Administrator, approved by the American Medi-cal Records Association.

Chairman, chief—The director of a medical, clinical service; the term alwaysconnotes a physician unless otherwise stated.

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Chief executive officer—A job descriptive term used to identify the indi-vidual appointed by the governing body to act in its behalf in the overall man-agement of the hospital.

Clinical privileges—Permission to render medical care in the granting insti-tution rendered pursuant to Chapter 107 (relating to medical staff).

Compliance directive—A directive issued by the Department citing deficien-cies which have come to the attention of the Department through the surveyprocess or by on-site inspection and directing the hospital to take correctiveaction as the Department directs or to submit a plan of correction.

Consultant—One who provides professional advice or services on request.Deficiency—Any condition which exists contrary to, in violation of, or in

noncompliance with this subpart.Department—The Department of Health of the Commonwealth. Where a

provision of this subpart confers powers or imposes duties upon the Depart-ment, which under a statute may be exercised by or imposed on only the Sec-retary, the reference to the Department shall be construed to mean the Depart-ment acting by and through the Secretary, or the person for the time beingacting as the Secretary, personally.

Dietetic assistant—A person who has completed a program in food serviceadministration and nutritional care which meets the training standards estab-lished by the American Dietetic Association and provides at least 90 clockhours of coursework.

Dietetic technician—A person who has completed an associate degree pro-gram which meets the educational standards established by the American Dieti-tian Association; this person works under the direction of a qualified dietitian.

Direction—Authoritative policy or procedural guidance for the accomplish-ment of a function or activity.

Director—An individual with administrative responsibility for the directionof a division or service of the hospital. When this term is used in connectionwith a medical, clinical service, it is synonymous with chairman and does notnecessarily imply a salaried or otherwise remunerated individual.

Division—An organizational division in the hospital.Drug administration—An act in which a single dose of an identified drug is

given to a patient.Drug dispensing—The issuance of floor stocks or of one or more doses of a

prescribed medication in containers that are correctly labeled to indicate thename of the patient, the contents of the container, and all other vital informa-tion needed to facilitate correct patient usage and drug administration.

Emergency contraception—(i) A drug, drug regime or device approved by the Food and Drug

Administration that is used after sexual intercourse to inhibit or prevent ovu-lation or fertilization.

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(ii) The term also includes a drug, drug regime or device approved bythe Food and Drug Administration that is used after sexual intercourse toinhibit or prevent the implantation of a fertilized ovum within the uterus.

Existing hospital—A facility erected or remodeled for use as a hospital priorto the effective date of this subpart.

Ex officio—Position by virtue of or because of an office, with no referenceto specific voting power.

Facilities—Buildings, equipment, and supplies necessary for implementationof hospital services by personnel.

Full-time—The normal or standard working period established by the hospi-tal.

General hospital—A hospital equipped and staffed for the treatment of medi-cal or surgical conditions, or both, in the acute or chronic stages, on an inpa-tient basis of 24 or more hours.

Graduate nurse—A graduate of an approved program of professional nurs-ing practicing his profession pursuant to and in accordance with The Profes-sional Nursing Law (63 P. S. §§ 211—225).

Graduate social worker—A person qualified by a graduate degree from aschool of social work accredited by the Council on Social Work Education.

Hospital—A facility having an organized medical staff and providing equip-ment and services primarily for inpatient care to persons who require definitivediagnosis or treatment, or both, for injury, illness, pregnancy, or other disabil-ity.

House staff/House staff officers—Physicians in training whose clinical privi-leges are delineated pursuant to Chapter 107.

Licensed practical nurse—A person licensed to practice practical nursingpursuant to The Practical Nurse Law (63 P. S. §§ 651—667).

May—A term used to indicate an acceptable but not mandatory standard,method, process, or result.

Medical—Of, pertaining to, or dealing with the healing art and the scienceof medicine or osteopathy.

Must—Synonymous with shall.

New construction—New buildings, additions to existing buildings, conver-sion of existing buildings or portions thereof, or portions of buildings undergo-ing alterations other than repair.

Nuclear medicine—The scientific and clinical discipline concerned withdiagnostic, therapeutic-exclusive of sealed radium sources, and investigativeuse of radionuclides.

Nursing care unit—An organized jurisdiction of nursing service in whichnursing services are provided on a continuous basis.

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Nursing service—Patient care services pertaining to the curative, restorative,and preventative aspects of nursing that are performed or supervised by a reg-istered nurse pursuant to the medical care plan of the practitioner and the nurs-ing care plan.

Nursing station—The physical area within a patient care unit from whichnursing services are provided and where nursing records and supplies are main-tained.

Organized—Administratively and functionally structured.Organized medical staff—A formal organization of physicians, and dentists

with the delegated responsibility and authority to maintain proper standards formedical care.

Outpatient service—An organizational unit of the hospital which is designedto support the provision of nonemergency health care services to patients whodo not remain in the hospital overnight; the term includes a short-term proce-dure unit when applicable.

Paramedic—An emergency medical technician specifically trained in anadvanced program of emergency cardiac and noncardiac care and certified bythe Department as qualified to render the services enumerated in section 3 ofthe act of November 30, 1976 (P. L. 1205, No. 264) (35 P. S. § 6803) otherwiseknown as an emergency medical technician—paramedic or EMT—paramedic.

Patient care unit—A designated area of the hospital where nursing servicesare provided on a continuous basis.

Pharmacy—Any place where the practice of pharmacy is conducted pursu-ant to the Pharmacy Act (63 P. S. §§ 390-1—390-13).

Physician—A person licensed to practice medicine or osteopathy. The termis more fully defined in 1 Pa.C.S. § 991.

Policy—A heading designating a section of this subpart which is a duty orresponsibility only of the Department. Policy regulations carry the force of lawwhen applied to the Department but do not apply to hospitals under this sub-part.

Practice privileges—Synonymous with clinical privileges.Practitioner—A licensed physician, dentist, or podiatrist.Principle—A term used to indicate the general approach or objective to be

accomplished by meeting the standards or other regulations appearing after thestated principle.

Professional nurse/registered professional nurse—A person licensed to prac-tice professional nursing pursuant to The Professional Nursing Law (63 P. S.§§ 211—225).

Provider—An individual; a trust or estate; a partnership; a corporationincluding associations, joint stock companies, and insurance companies; andthe Commonwealth or a political subdivision or instrumentality thereof includ-ing a municipal corporation or authority that operates a health care facility.

Qualified dietitian—A person who:

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(i) Is registered or eligible for registration by the Commission onDietetic Registration and has at least one year of experience in clinicaldietetics and nutrition; or

(ii) Has a baccalaureate degree or advanced degree with major studiesin food or nutrition of dietetics and who has at least one year of clinicalexperience.Qualified nurse anesthetist—A nurse who has been certified as a nurse anes-

thetist by the American Association of Nurse Anesthetists or who has theequivalent training and experience.

Qualified records administrator—Either an Accredited Records Technicianor a Registered Records Administrator, approved by the American MedicalRecords Association.

Radiologic technologist—An individual who is a graduate of a program inradiologic technology approved by the Council on Medical Education of theAmerican Medical Association or who has the equivalent of such education andtraining.

Rape crisis center—An office, institution or center that offers assistance to asexual assault victim or the victim’s family through crisis intervention, medicaland legal accompaniment and follow-up counseling.

Reportable communicable disease—Any disease for which reports arerequired pursuant to the provisions of the Disease Prevention and Control Lawof 1955 (35 P. S. §§ 521.1—521.21). Reference should also be made to Chap-ter 27, Subchapters B, E and F (relating to selected procedures for preventingdisease transmission; and miscellaneous provisions).

Respiratory therapy—The provision of ventilatory support and associatedservices to patients.

Secretary—The Secretary of the Department.Service—Used to indicate a functional division of the hospital or of the

nursing or medical staff; also used to indicate the delivery of care.Sexual assault—Any offense specified in 18 Pa.C.S. Chapter 31, Subchapter

B (relating to definition of offenses), except that the term does not includeindecent exposure as defined in 18 Pa.C.S. § 3127 (relating to indecent expo-sure) or sexual intercourse with an animal as defined in 18 Pa.C.S. § 3129(relating to sexual intercourse with animal).

Sexual assault counselor—A person who is engaged or employed by a rapecrisis center that arranges for the provision of services to a sexual assault vic-tim, who has undergone at least 40 hours of sexual assault training and is underthe control of a direct services supervisor of a rape crisis center, whose primarypurpose is the rendering of advice, counseling or assistance to victims of sexualassault.

Sexual assault emergency services—A medical examination, forensic exami-nation, or other procedure or service provided by a hospital to a sexual assaultvictim because of a sexual assault.

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Sexual assault victim or victim—A person who has been sexually assaulted.Short-term procedure unit—A unit organized for the delivery of nonemer-

gency surgical services to patients who do not remain in the hospital overnight.Small hospital—A hospital maintaining 100 beds or less, as licensed by the

Department.Special care unit—An appropriately equipped area of the hospital where

provision has been made for a concentration of physicians, nurses, and otherswho have special skills and experiences to provide medical care for criticallyill patients.

Special hospital—A hospital equipped and staffed for the treatment of disor-ders within the scope of specific medical specialties or for the treatment oflimited classifications of diseases in their acute or chronic stages on an inpa-tient basis of 24 or more hours.

Survey—The process of evaluation or reevaluation of the compliance of ahospital with this subpart.

Undergraduate social worker—A person qualified by a bachelor’s degreefrom an undergraduate program in social work accredited by the Council onSocial Work Education.

Unit—A functional facility of the hospital.

Authority

The provisions of this § 101.4 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and under 803 of the Health Care Facilities Act (35 P. S. § 448.803); amendedunder sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. §§ 448.102,448.201(12), 448,801a and 448.803(2)); and under section 2102(a) and (g) of The AdministrativeCode of 1929 (71 P. S. § 532(a) and (g)).

Source

The provisions of this § 101.4 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4192 and 4281; amended January 25, 1985, effective March 27, 1985, 15 Pa.B. 250;amended January 25, 2008, effective January 26, 2008, 38 Pa.B. 573. Immediately preceding textappears at serial pages (244992) to (244994), (287187) to (287188) and (244997).

§ 101.5. [Reserved].

§ 101.6. Contact person.

Any person having questions or comments concerning this subpart may addressthose questions or comments to:

Bureau of Quality AssurancePennsylvania Department of HealthPost Office Box 90Harrisburg, Pennsylvania 17108

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Authority

The provisions of this § 101.6 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and under 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.6 adopted December 3, 1982, effective December 4, 1982, 12 Pa.B.4129.

EXCEPTIONS

§ 101.11. Principle.The Department may, and for justifiable reason, grant exceptions to and depar-

tures from this subpart when the policy objectives and intentions of this subpartare otherwise met or when compliance would create an unreasonable hardship butwould not impair the health, safety, or welfare of any patient.

§ 101.12. Exceptions for innovative programs.This subpart is not intended to restrict the efforts of any hospital to develop

innovative and improved programs of management, clinical practice, physicalrenovation, or structural design. Whenever the provisions of this subpart appearto preclude any program which may improve the capacity of the hospital todeliver higher quality care and services or to operate more efficiently, the Depart-ment encourages the hospital to request appropriate exceptions pursuant to thischapter.

§ 101.13. Requests for exceptions.Requests for exceptions to this subpart shall be made in writing to the Depart-

ment. Such requests, whether approved or not approved, will be documented andretained on file by the Department. Approved requests shall be retained on fileby the hospital applicant during the period the exception remains in effect.

§ 101.14. Revocation of exceptions.(a) Any exception granted under this chapter may be revoked by the Depart-

ment for any justifiable reason. Notice of revocation will be in writing and willinclude the reason for the action of the Department and a specific date uponwhich the exception will be terminated.

(b) In revoking an exception, the Department will provide for a reasonabletime between the date of written notice of revocation and the date of terminationof an exception for the hospital to come into compliance with the applicableregulations. Failure by the hospital to comply after the specified date may resultin enforcement proceedings under this chapter.

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(c) If a hospital wishes to request a reconsideration of a denial or revocationof an exception, it must do so in writing to the Director of the Bureau of QualityAssurance of the Department within 30 days of receipt of the adverse notifica-tion.

Authority

The provisions of this § 101.14 issued under 67 Pa.C.S. §§ 6101—6104 (Repealed); and Reorga-nization Plan No. 2 of 1973 (71 P. S. § 755-2) (Renumbered).

Source

The provisions of this § 101.14 amended September 19, 1980, effective September 20, 1980, 10Pa.B. 3761. Immediately preceding text appears at serial page (37757).

CLASSIFICATION OF HOSPITALS

§ 101.21. Classification.Every hospital licensed under this subpart shall be designated as either a gen-

eral or special hospital, and this classification shall be noted on its license.

Authority

The provisions of this § 101.21 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.21 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (66821).

HOSPITAL REQUIREMENTS

§ 101.31. Hospital requirements.A hospital shall have all of the following:

(1) An organized governing body.

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(2) A chief executive officer.(3) An organized medical staff.(4) An organized nursing staff.(5) Medical services, continuous.(6) Nursing services, continuous.(7) Permanent on-site facilities for the care of patients 24 hours a day.(8) A hospital-wide infection control program.(9) Minimum on-site clinical provisions as follows:

(i) Inpatient care areas equipped with hospital furnishings.(ii) Nursing care units.(iii) Diagnostic and treatment areas.(iv) Supplies and equipment to meet the medical and nursing needs of

the patients within the scope of the services provided.(v) Pharmaceutical services in compliance with Chapter 113 (relating to

pharmacy services).(vi) Facilities for the sterilization of equipment and supplies.(vii) Treatment equipment for drug, blood, and parenteral fluid adminis-

tration and for performance of medical or surgical nursing procedures.(viii) Treatment equipment for the management of common medical or

surgical, or both, emergencies, including facilities for cardio-pulmonaryresuscitation.

(ix) Medical records services.(x) Provision for medical social work services in compliance with

Chapter 121 (relating to social work services).(xi) Professional library services in compliance with Chapter 145 (relat-

ing to professional library services).(xii) Provision for therapeutic diets.

(10) Minimum supportive capabilities or facilities as follows:(i) A safe, structurally sound, habitable, sanitary, fire-resistant physical

plant designed and equipped specifically for the delivery of contemporaryforms of hospital care.

(ii) Facilities to provide adequate heat, light, ventilation, potable water,sewage disposal, electrical power, internal and external communications, andemergency utility services.

(iii) Sanitary garbage, trash, and waste disposal.(iv) Internal and external environmental sanitation services.(v) Sanitary laundry services for hospital garments and linens.(vi) Sanitary hospital dietary services.(vii) An internal fire and disaster plan, fire alarm system and evacuation

plan.(viii) Scheduled general and preventive maintenance services for build-

ing, services and biomedical equipment.

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(ix) Participation with community agencies in the establishment of therole of the hospital in event of external disasters.

(x) Capability for obtaining police and fire protection, emergency trans-portation, grounds-keeping and snow removal.

(xi) Personnel recruitment, training and continuing education.(xii) Business management capability.(xiii) Short- and long-range planning capability.(xiv) Fiscal services to assure continuity of operation under both normal

and emergency conditions.(xv) Comprehensive policies and standards for assuring the safety of

patients, employes and visitors and for protection against malpractice andnegligence.

Authority

The provisions of this § 101.31 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.31 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (66822).

Cross References

This section cited in 55 Pa. Code § 1181.2 (relating to definitions); and 55 Pa. Code § 1187.2(relating to definitions).

INITIAL APPLICATION AND AUTHORIZATION TOOPERATE A HOSPITAL

§ 101.41. Principle.The Department will grant the initial license to operate a new hospital after a

survey conducted by the Department indicates that the applicant is in compliancewith applicable provisions of this subpart. Such survey shall include an on-siteinspection and review of written approvals submitted to the Department by regu-latory agencies responsible for building, electric, fire, and environmental safety.

Authority

The provisions of this § 101.41 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.41 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (66823).

Cross References

This section cited in 28 Pa. Code § 101.43 (relating to request for application).

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§ 101.42. Building occupancy.

New construction, alterations, or renovations that provide space for patient ser-vices or patient rooms shall not be used or occupied until authorization for suchoccupancy has been received by the hospital from the Department. It is theresponsibility of the hospital to request a preoccupancy survey at least two weeksprior to the anticipated occupancy of a hospital or any addition or remodeled partthereof. The Department will conduct an on-site survey of the new or remodeledportion of the hospital prior to granting approval for occupancy. The Department,acting through the Director of the Division of Hospitals, may give such authori-zation orally, either in person or by telephone. The Department will provide thehospital with written confirmation of such oral authorization within 30 days.

Authority

The provisions of this § 101.42 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803), unlessotherwise noted.

Source

The provisions of this § 101.42 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial pages (66823) and (52722).

Cross References

This section cited in 28 Pa. Code § 101.43 (relating to request for application).

§ 101.42a. Code compliance.

A hospital shall meet the edition of the National Fire Protection Association101, Life Safety Code and all applicable appendices which are currently enforcedby the Federal government. Hospitals previously in compliance with prior edi-tions of the Life Safety Code will be deemed in compliance with any subsequentedition with the exception of any new renovation or construction, which shallmeet the current standard.

Authority

The provisions of this § 101.42a issued under section 803 of the Health Care Facilities Act (35P. S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

Source

The provisions of this § 101.42a adopted January 20, 1984, effective January 21, 1984, 14 Pa.B.215.

Cross References

This section cited in 28 Pa. Code § 101.43 (relating to request for application).

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§ 101.43. Request for application.The Department will supply the necessary forms for application under

§§ 101.41, 101.42 and 101.42a (relating to principle; building occupancy; andcode compliance).

Authority

The provisions of this § 101.43 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.43 amended January 20, 1984, effective January 21, 1984, 14 Pa.B.215. Immediately preceding text appears at serial page (77204).

CONTINUING OPERATIONS

§ 101.51. Policy.The Department will issue a license valid for two years to any hospital which

is in compliance with this subpart.

Authority

The provisions of this § 101.51 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.51 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (52722).

§ 101.52. Nontransfer of license.A hospital shall advise the Department no later than 90 days prior to an

intended change of ownership or control of the hospital. No license shall betransferable to new owners or controlling parties except upon a finding by theDepartment that they are responsible persons.

Authority

The provisions of this § 101.52 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this §§ 101.52 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (52722).

§ 101.53. Void license.The license of a hospital becomes automatically void when any or all of the

following occur:(1) The license term expires.

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(2) The hospital substantially changes its name or location, in which casea new license will be automatically issued upon application by a hospital if thehospital is otherwise in compliance with the applicable provisions of this sub-part.

(3) If the hospital locates or relocates services at a site other than the cur-rent, contiguous site, it shall notify the Department 30 days prior to suchchange in order that the Department may determine if a new license is neces-sary.

Authority

The provisions of this § 101.53 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.53 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (52722).

§ 101.54. Inpatient bed complement.A license is issued for approved existing facilities and bed complement. A hos-

pital shall notify the Department when increases in bed complement are sched-uled according to the following guidelines:

(1) If the increased bed complement will increase the total number of bedsby more than ten beds or by more than 10% of the total bed capacity, the hos-pital shall not utilize the increased capacity until approval is obtained from theDepartment.

(2) If the hospital increases the bed complement by not more than ten bedsor 10% of the total bed capacity, whichever is less, during a period of a license,prior approval of the Department is not required, although notification of thechange must still be made. A hospital must at all times meet the physical plant,staffing, and all other requirements, as defined by this chapter, if additionalbeds are added.

Authority

The provisions of this § 101.54 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.54 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (52723).

§ 101.55. Display of license.The current license shall be displayed in a public and conspicuous place in the

hospital.

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Authority

The provisions of this § 101.55 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.55 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (52723).

§ 101.56. Licensure information/application.(a) Information regarding licensure must be completed annually on forms

supplied by the Department. The Annual Hospital Questionnaire shall be com-pleted each year; the Application for Hospital Licensure shall be completed bien-nially.

(b) If a hospital operates any number or variety of separate or distinct clini-cal facilities and has been issued a single license, information requested on thequestionnaire and application forms must be separate and distinct according tolocation of facilities listed.

Authority

The provisions of this § 101.56 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.56 adopted December 3, 1982, effective December 4, 1982, 12 Pa.B.4129.

INSPECTION AND SURVEY OF ACTIVITIES

§ 101.61. Policy.Representatives of the Department will biennially conduct a survey of every

hospital required to be licensed under this subpart or will conduct surveys inconjunction with representatives of accrediting agencies in Appendix A and inaccordance with § 101.62 (relating to combined survey).

Authority

The provisions of this § 101.61 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.61 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (52723).

§ 101.62. Combined survey.(a) A provider may request that the Department consider, during the determi-

nation of the Department whether a particular hospital is in compliance with these

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regulations, the survey report of the Federal government or a nationally recog-nized accrediting agency if the provider has been issued a regular license cover-ing the particular hospital to be surveyed for the last 3 years.

(b) If a provider requests to be licensed in accordance with subsection (a), itmust submit to the Department a copy of the accrediting survey report of theagency within 7 days of receipt.

(c) If a provider requests to be licensed in accordance with subsection (a), itmust comply with all requirements of this subpart. The requirements that are notcovered by the standard survey of each approved accrediting agency are listed inAppendix B.

(d) The Department will have the sole authority to accept or reject, in wholeor in part, the findings of the accrediting agency.

(1) If the accrediting findings of the agency are rejected, a full or partialsurvey at the discretion of the Department will be conducted by the surveyorsof the Department to determine whether a license can be issued.

(2) If the accrediting agency denies accreditation to a provider, a full Statesurvey will be conducted to determine whether a license can be issued.

(3) If a provider chooses not to apply for a license through the accreditingprocedure even though qualified to do so under this section, a full State surveywill be conducted to determine whether a license can be issued.

(4) For those portions of the accrediting agency survey report which theDepartment accepts as evidence that the provider is meeting the provisions ofthis subpart, the provider will be considered to be in full compliance with thecorresponding provisions of this subpart.

Authority

The provisions of this § 101.62 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.62 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129 and 4281. Immediately preceding text appears at serial pages (52723) to (52724).

Cross References

This section cited in 28 Pa. Code § 101.61 (relating to policy).

§ 101.63. Department responsibilities.The Department will provide the Department of Environmental Protection with

its schedule for biennial hospital licensure inspections at a reasonable time inadvance of such inspections. It will also be responsible for updating this schedulepromptly as required in the event of any changes. The Department will exertevery effort to coordinate and cooperate with DER in the exercise of their dutiesto enforce all applicable environmental, health, sanitation and safety standardsunder their jurisdiction.

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Authority

The provisions of this § 101.63 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.63 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial pages (52725) and (37762).

§ 101.64. Hospital responsibilities.A hospital shall comply with all applicable environmental, health, sanitation,

and life-safety standards which are not under the direct jurisdiction of the Depart-ment. This shall include, but not be limited to, radiologic health, sanitation, foodservice, pharmacy, electric wiring and life-safety code compliance. When thehospital has been inspected by another regulatory agency, it shall have on therecord during the survey by the Department written confirmation of complianceas provided by the rules and regulations of appropriate agencies.

§ 101.65. Notice of biennial survey.The Department will give reasonable notice to a hospital of its intent to con-

duct the site visit component of the biennial survey.

Authority

The provisions of this § 101.65 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.65 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (37762).

§ 101.66. Presurvey preparation.Prior to a biennial survey site visit of a hospital by the Department, the Depart-

ment may request from the hospital any documents, records, necessary consentsto review the records of the hospital held by other organizations or agencies, orother information necessary for the Department to prepare for the site visit. Thehospital shall provide any and all information or consents so requested.

Authority

The provisions of this § 101.66 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.66 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (37762).

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§ 101.67. Access by the Department.(a) Upon presenting the official Department of Health identification card to

the hospital’s chief executive officer or his designee, authorized agents of theDepartment shall have access to the hospital to determine compliance with thissubpart. Such access shall include:

(1) Entry to all hospital premises.(2) Inspection and examination of all of the facilities, records, documents,

and phases of operations, as permitted by law, including those relating to com-pliance with Chapter 103 (relating to governance and management).

(3) Interviewing of any staff, employes, members of the governing bodyand patients, subject to subsection (b).

(4) Examination of any patient, with his consent.(b) The Department will not interview any patient in intensive care or for

whom the order of the attending physician specifically limits visitors, withoutfirst seeking the consent of the attending physician.

§ 101.68. Site survey coverage.The Department may survey onsite only those aspects of the hospital as it

deems necessary to fully and fairly assess the compliance of the hospital with thissubpart.

§ 101.69. Documentation.The Department will document the extent of the compliance of a hospital with

this subpart in at least one of the following ways:(1) The statement of a responsible, authorized administrator or staff mem-

ber.(2) Documentary evidence provided by the facility.(3) Answers by the hospital to detailed questions provided by the Depart-

ment concerning the implementation of any provision of this subpart orexamples of such implementation which will enable a judgment about compli-ance to be made.

(4) On-site observation by surveyors.(5) Interviews with patients, employes or other persons or sources capable

of providing reliable information to the Department.

Authority

The provisions of this § 101.69 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.69 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (37763).

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POSTSURVEY PROCEDURES

§ 101.71. Policy.After completion of the site visit, the Department will evaluate all relevant

information gathered during the survey, formulate its compliance findings anddeterminations, notify the hospital of its findings and determinations, and orderthe hospital to correct, within a specified period of time, any deficiencies found.

§ 101.72. Compliance directive.(a) In the event of noncompliance with any provision of this subpart, the

Department will notify the hospital, in writing, of any deficiencies and will directthe officers governing or managing the hospital to take such corrective action asthe Department directs or to submit a plan of correction, or to do both, within thetime specified by the Department. In its compliance directive and request for planof correction, the Department will state its findings and the reasons for its deter-mination.

(b) The hospital shall be presumed to be in compliance with any provision ofthis subpart for which the compliance directive does not cite a deficiency.

§ 101.73. Submission of plan of correction.Unless Federal regulations require an earlier submission, a plan of correction

shall be submitted to the Department within the period specified by the Depart-ment. The plan shall be attested to by the signature of the chairman of the gov-erning body or the chief executive officer. The plan of correction shall be submit-ted to the governing body as a whole for its review at its next regular meeting.

§ 101.74. Content of plan of correction.A plan of correction shall address all deficiencies cited in the compliance

directive of the Department. The plan shall state specifically what correctiveaction is to be taken, by whom, and when.

§ 101.75. Public inspection of compliance documents.Copies of compliance directives and plans of correction will be kept readily

available by the Department’s Division of Hospitals or its successor in appropri-ate regional offices for the purpose of public inspection, examination, and dupli-cation at a reasonable cost. Each hospital shall make available for inspection andexamination by any person a current copy of these documents provided to it bythe Department.

Authority

The provisions of this § 101.75 issued under 67 Pa.C.S. §§ 6101—6104 and Reorganization PlanNo. 2 of 1973 (71 P. S. § 755-2).

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Source

The provisions of this § 101.75 amended September 19, 1980, effective September 20, 1980, 10Pa.B. 3761. Immediately preceding text appears at serial page (37764).

CONTINUING SURVEILLANCE

§ 101.81. Unannounced surveys.Whenever the Department has received any complaint or has other reasonable

grounds to believe that a deficiency exists, the Department may without notice tothe hospital, investigate, inspect or survey any service, facility, or portion of thehospital to which the alleged deficiency relates.

ISSUANCE OF LICENSE

§ 101.91. Principle.The Department will issue hospital licenses to qualified facilities. The license

will reflect a regular or provisional status of the hospital. The license shall applyonly to those facilities designated.

Authority

The provisions of this § 101.91 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 808 of the Health Care Facilities Act (35 P. S. § 448.808).

Source

The provisions of this § 101.91 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (52727).

§ 101.92. Regular license.(a) The Department will issue a regular 2-year license to a hospital when that

hospital is in full compliance with section 808 of the act (35 P. S. § 448.808) andis in full or substantial compliance with the provisions of this subpart.

(b) As used in subsection (a), ‘‘full compliance’’ means total compliance; asused in subsection (a), ‘‘substantial compliance’’ means:

(1) That any deficiencies are, individually and in combined effect, of aminor nature such that neither the deficiencies nor efforts toward their correc-tion will:

(i) Interfere with or adversely affect normal hospital operations; or(ii) Adversely affect any patient’s health or safety; and

(2) That the hospital has adopted a plan of correction approved by theDepartment.

Authority

The provisions of this § 101.92 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 808 of the Health Care Facilities Act (35 P. S. § 448.808).

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Source

The provisions of this § 101.92 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial pages (52727) to (52728) and (37766).

Cross References

This section cited in 28 Pa. Code § 101.101 (relating to grounds); 28 Pa. Code § 101.102 (relatingto modification of license); and 28 Pa. Code § 101.111 (relating to policy).

§ 101.93. Provisional license.(a) The Department may issue a provisional license, valid for a specified time

period of no more than 6 months, when there are numerous deficiencies or a seri-ous specific deficiency in compliance with applicable statutes, ordinances orregulations but when:

(1) The hospital is taking appropriate steps to correct the deficiencies inaccordance with a timetable submitted by the hospital and agreed upon by theDepartment.

(2) There is no pattern of repeat deficiencies over a period of 2 or moreyears.(b) A provisional license may be renewed no more than three times at the

discretion of the Department.(c) A provisional license may not be issued to allow services or facilities, or

parts of facilities, which are subject to Certificate of Need review, but have notbeen submitted for such review, to be operated pending completion of Certificateof Need review.

Authority

The provisions of this §§ 101.93 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 808 of the Health Care Facilities Act (35 P. S. § 448.808).

Source

The provisions of this § 101.93 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (37766).

Cross References

This section cited in 28 Pa. Code § 101.101 (relating to grounds); and 28 Pa. Code § 101.102(relating to modification of license).

REFUSAL OR REVOCATION

§ 101.101. Grounds.(a) The Department may revoke or refuse to issue a license for any of the

following reasons:(1) Failure to comply with any compliance directive issued by the Depart-

ment.

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(2) Violation of or noncompliance with this subpart except when the hos-pital is in full compliance or substantial compliance as defined in § 101.92(b)(relating to regular license) or otherwise meets the conditions set forth in§ 101.93 (relating to provisional license).

(3) Failure to correct any deficiency pursuant to a plan of correction,unless the Department approves an extension or modification of the plan ofcorrection.

(4) Gross incompetence, negligence or misconduct in operating the hospi-tal.

(5) Fraud, deceit, misrepresentation or bribery in obtaining or attempting toobtain a license.

(6) Lending, borrowing, or using the license of another hospital.(7) Knowingly aiding or abetting in any way the improper granting of a

license.(8) Mistreating or abusing individuals cared for by the hospital.(9) A pattern of continued noncompliance, in disregard of regulations,

which is corrected only when actively supervised by the Department.(b) Failure to obtain a Certificate of Need will necessitate a licensure modi-

fication to exclude the service lacking certificate of need approval.

Authority

The provisions of this § 101.101 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.101 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial pages (37766) to (37767).

§ 101.102. Modification of license.

The Department may modify a license by substituting a provisional license fora regular license whenever the Department determines that the hospital is not infull compliance or substantial compliance as defined in § 101.92(b) (relating toregular license) but the hospital otherwise meets the requirements of § 101.93(b)(relating to provisional license).

Authority

The provisions of this § 101.102 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.102 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (37767).

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§ 101.103. Notice.Whenever the Department proposes to revoke, modify or refuse to issue a

license or to issue a provisional license, or to suspend admissions or withholdsState funds available to the hospital, it will give written notice to the hospital bycertified mail.

Authority

The provisions of this § 101.103 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.103 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (37767).

Cross References

This section cited in 28 Pa. Code § 101.104 (relating to form of notice); and 28 Pa. Code§ 101.121 (relating to demand for hearing).

§ 101.104. Form of notice.A notice under § 101.103 (relating to notice) will conform to 1 Pa. Code

§ 35.14 (relating to orders to show cause). The order will specify the reasons forthe proposed action of the Department and will notify the hospital of its right toa hearing. The order will specify the time within which the request of the hospi-tal for a hearing must be filed with the Department.

Authority

The provisions of this § 101.104 issued under sections 2101—3002 of The Administrative Codeof 1929 (71 P. S. §§ 531—732); Articles IX and X of the Public Welfare Code (62 P. S. §§ 901—1059); and Reorganization Plan No. 3 of 1975.

Source

The provisions of this § 101.104 adopted December 9, 1977, 7 Pa.B. 3631.

CORRECTION OF DEFICIENCY

§ 101.111. Policy.Whenever any hospital notifies the Department that it has completed a plan of

correction and corrected its deficiencies, the Department will conduct a survey toascertain completion of the plan of correction. Upon finding full or substantialcompliance, as defined in § 101.92(b) (relating to regular license), the Depart-ment may issue a regular license.

Authority

The provisions of this § 101.111 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

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Source

The provisions of this § 101.111 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (37768).

HEARINGS

§ 101.121. Demand for hearing.The Department will convene and conduct a hearing for any hospital which

requests, in accordance with 1 Pa. Code § 35.37 (relating to answers to orders toshow cause) and this chapter, a hearing to contest an order to show cause issuedpursuant to § 101.103 (relating to notice).

§ 101.122. Conduct of proceedings.Any administrative hearing held pursuant to this subpart shall be conducted in

accordance with 1 Pa. Code Part II (relating to general rules of administrativepractice and procedure).

ADDITIONAL REMEDIES

§ 101.141. Principle.The Department will enforce this subpart and its recommendations and direc-

tives through all lawful and appropriate means.

§ 101.142. Withhold State funds.After proper notice and the opportunity for a hearing, the Department may

withhold, in whole or in part, any and all State funds available to any hospitalwhich does either:

(1) Fails to comply with a compliance directive without having timelyrequested a hearing.

(2) Operates without a valid license.

Authority

The provisions of this § 101.142 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.142 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (37769).

§ 101.143. Judicial proceedings and injunctions.The Department may request the Office of Attorney General to institute appro-

priate legal proceedings to enforce compliance with this subpart.

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Authority

The provisions of this § 101.143 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.143 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (37769).

CHILD ABUSE

§ 101.151. Principle.All hospitals shall comply with the Child Protective Services Law, 23 Pa.C.S.

§§ 6301—6384, and with any regulations promulgated thereunder by the Depart-ment of Public Welfare.

CIVIL RIGHTS

§ 101.161. Principle.Hospitals shall comply with the Pennsylvania Human Relations Act (43 P. S.

§§ 951—963) and 16 Pa. Code Part II, Subpart A (relating to Human RelationsCommission).

§ 101.162. Civil rights compliance.Civil rights compliance shall be a condition required for the issuance of a

license. The Department may make onsite visits at its discretion to verify the civilrights compliance status of the hospital.

Authority

The provisions of this § 101.162 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.162 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (52730).

§ 101.163. Compliance requirements.(a) Inpatient and outpatient care including all clinic locations, emergency

room care and any contracted services for patients shall be provided withoutregard to race, color, national origin, sex or sexual preference or religion.

(b) All patients shall be assigned to rooms, floors and sections in accordancewith their medical needs.

(c) Patients shall not be asked whether they are willing or desire to share aroom with a person of another race or religion.

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(d) Employes shall be assigned to patient services without regard to the race,color, national origin, or religion of either the patient or employe.

(e) Transfer of patients from rooms assigned or selected, or both, shall not bemade for other than valid medical reasons.

(f) At discharge, patients shall be referred only to those skilled nursing carefacilities, intermediate care facilities, personal care facilities or foster homeswhich are not known to the hospital to be in noncompliance with the provisionsof the Pennsylvania Human Relations Act (43 P. S. §§ 951—963). The hospitalshall report immediately to the Compliance Office of the Department all instancesof posthospital discriminatory practices experienced by patients referred by thehospital when such practices are brought to the attention of the hospital.

(g) All training programs and opportunities offered by the hospital shall beopen to qualified applicants without regard to race, creed, color, national origin,sex, or, in nonsectarian hospitals, religion; and recruitment efforts for these shallinclude sources having potential racial minority applicants.

§ 101.164. Civil rights compliance records.The following records shall be maintained to indicate that no person is

excluded from participation in, is denied the benefits of, or is otherwise subjectedto discrimination in the provision of any care or services on the ground of race,creed, color, sex, sexual preference, national origin or religion.

(1) A signed and dated copy of the policies of the hospital pertaining to theadmission of patients and visitors. The date the policies were adopted shall alsobe indicated. The policies shall set forth in clear terms nondiscriminatory prac-tices with regard to race, creed, color, religion, national origin, sex or sexualpreference.

(2) Copies of signed and dated notification forms by which doctors andother persons who normally refer to admit patients to the hospitals have beeninformed of the nondiscriminatory admission policy of the hospital.

(3) A copy of the date, notification, and description of the continuingmethod used to inform employes of the nondiscriminatory policies.

(4) Evidence that nondiscriminatory practices of the facility have beenpublicized in the community by one of the following methods: newspaper,radio, television, brochure, yellow pages in the telephone book, patient hand-books and so on.

(5) Records, by race, showing the utilization of inpatient rooms; intensivecare and other units; outpatient clinics; emergency rooms; and referrals tonursing homes or other posthospital care facilities, homes, or agencies andshowing the participation in training programs for such periods of time as maybe required by the Department to determine compliance with the PennsylvaniaHuman Relations Act (43 P. S. §§ 951—963).

(6) Written personnel policies giving evidence that employment practicesof the hospital are in conformity with the Pennsylvania Human Relations Act

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(43 P. S. §§ 951—963). These policies shall be made available to all employesand shall be discussed with each new employe.

(7) The stated ethical policy of the hospital, as defined in 16 Pa. Code§ 51.2 (relating to definitions) with regard to abortion or sterilization if thehospital has adopted such a policy pursuant to 16 Pa. Code § 51.31 (relating toadoption and substance of a stated ethical policy) and any written objections toparticipating in such procedures submitted by any employe or staff memberpursuant to 16 Pa. Code § 51.41 (relating to written objection to performance,participation in or cooperation in abortion or sterilization procedures).

(8) Such other records or reports as may be required by the Department,from time to time, to determine compliance with the Pennsylvania HumanRelations Act (43 P. S. §§ 951—963). This includes the competion of theDepartment’s Civil Rights Compliance Form.

Authority

The provisions of this § 101.164 issued under 67 Pa.C.S. §§ 6101—6104; and ReorganizationPlan No. 2 of 1973 (71 P. S. § 755-2).

Source

The provisions of this § 101.164 amended September 19, 1980, effective September 20, 1980, 10Pa.B. 3761. Immediately preceding text appears at serial pages (37770) to (37771).

§ 101.165. Ethnic language barriers.When it is substantiated that the regular patient population of the hospital con-

tains a foreign language speaking population for whom the language barrier con-stitutes a service disadvantage, the hospital should do all of the following:

(1) Have a roster of bilingual personnel or volunteers, or both.(2) Post bilingual signs and have other printed materials, such as hospital

handbooks, medical care instructions and follow-up care, readily available.

BED COMPLEMENT

§ 101.171. [Reserved].

Source

The provisions of this § 101.171 reserved December 3, 1982, effective December 4, 1982, 12Pa.B. 4129. Immediately preceding text appears at serial page (52732).

§ 101.172. Patient limits.The number of patients admitted to any area of the hospital shall not exceed

the number for which the area is designed, equipped, and staffed except in casesof emergency, and then only in accordance with the emergency or disaster planof the hospital.

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LICENSE FEES

§ 101.181. Principle.License fees will be charged and collected in accordance with section 807 of

the act (35 P. S. § 448.807).

Authority

The provisions of this § 101.181 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.181 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (52733).

MISCELLANEOUS PROVISIONS

§ 101.191. Multiple-clinical facilities.A general or special hospital or medical center may operate any number of

separate or distinct clinical facilities under its ownership and direct management.Such facilities may be structurally integrated or may be physically located else-where. The Department will rule on all requests for single licensing of multiple-clinical facilities according to pre-established criteria which are available fromthe Department. All such patient care facilities except physicians’ offices shall besubject to appropriate onsite inspection and survey to determine whether there iscompliance with applicable provisions of this subpart.

Authority

The provisions of this § 101.191 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

Source

The provisions of this § 101.191 amended through December 3, 1982, effective December 4, 1982,12 Pa.B. 4129. Immediately preceding text appears at serial page (52733).

§ 101.192. Owners or controlling persons.A hospital shall provide the Department with a written list of the names and

addresses of all persons having a 5.0% or more ownership or controlling interestin the hospital. As used in this section, ‘‘person’’ means any natural person, part-nership, or corporate entity, including any public agency or religious, fraternal orphilanthropic organization.

Authority

The provisions of this § 101.192 issued under 67 Pa.C.S. §§ 6101—6104 (Repealed); and Reor-ganization Plan No. 2 of 1973 (71 P. S. § 755-2) (Renumbered).

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Source

The provisions of this § 101.192 amended September 19, 1980, effective September 20, 1980, 10Pa.B. 3761. Immediately preceding text appears at serial page (37773).

§ 101.193. Incorporated hospitals.If a hospital is incorporated, it shall provide the Department, upon request, with

a written list of the names and addresses of the hospital or parent corporation’sofficers, directors, and principal stockholders, either beneficial or of record.

§ 101.194. Nonprofit corporation hospital.Every hospital which is organized as a nonprofit corporation shall file with the

Department a copy of its charter and articles of incorporation certified from thepublic record. It shall be the responsibility of the hospital to promptly submit tothe Department a copy of any amendments or changes to the original charter.

§ 101.195. [Reserved].

Source

The provisions of this § 101.195 reserved December 3, 1982, effective December 4, 1982, 12Pa.B. 4129 and 4281. Immediately preceding text appears at serial page (52734).

§ 101.196. Notice of closure.A hospital shall give written notice of an intent to close to the Department, not

later than 90 days prior to the anticipated date of closing.

[Next page is 103-1.]

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